DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Formal Matters
Claims 11-17 are cancelled. Claims 1 and 18 are currently amended. New claims 21 and 22 are added. Claims 1-10 and 18-22 are pending and under examination.
Response to Arguments
Applicant argues that Weir does not disclose all of the elements of the rejected claims and argues that Weir does not mention an adjustment of a jaw drive setting based on a characteristic that includes a stage of usable life of an instrument (Remarks, numbered page 6). Applicant argues that Weir only describes correcting a jaw angle based on wrist articulation (Remarks, numbered page 7).
Applicant states that the limitation to “adjustment information” has been clarified such that the adjustment information enable an adjustment of the setting information from a basis jaw drive setting to an adjusted jaw drive setting based on a characteristic of the instrument, wherein the characteristic of the instrument includes a stage of usable life of the instrument (Remarks, numbered pages 6 and 7).
Applicant argues that the information of Shelton is “contextual information” rather than “adjustment information” and that it is not related to the useable life of the instrument (Remarks, numbered pages 7-8). Applicant also argues hindsight bias regarding the Shelton reference due to its significant length.
Applicant’s arguments have been fully considered, but they are not persuasive. To the extent Applicant argues the references separately, the argument is not persuasive when the rejection is a combinatorial obviousness rejection. As stated of record and reiterated herein, Weir teaches the claimed surgical system, but does not teach that the characteristic of the instrument includes a stage of usable life of the instrument. Shelton teaches input couplers, end effectors comprising jaw members, and storage devices storing setting information comprising characteristics of the instruments including a stage of useable life of the instrument. Weir need not teach what is taught by Shelton.
Shelton’s situational awareness hub includes the same and overlapping components of the surgical system of Weir, a person of ordinary skill in the art seeking to control and coordinate the interrelated components would look to a storage device system or “hub” capable of orchestrating the complexities of the surgical system.
Applicant’s claim 1, lines 12-13 are drawn to the claimed surgical system comprising a storage device storing setting information and adjustment information. Lines 14-18 are drawn to functional aspects of the storage device comprising the adjustment information. Shelton teaches the storage device as a situational awareness surgical hub and all of its components and also teaches the function of the adjustment information, providing examples of how it can be used to adjust function of the system based on the stage of usable life of the instrument such as when “inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.” (¶1678).
Regarding the characterization of the “contextual information”, the relevant section of Shelton is drawn to “surgical hub situational awareness” (subtitle of section between ¶1054 and ¶1055). At ¶1055 Shelton expressly recites that “the control algorithm may control the modular device incorrectly or suboptimally given the particular context-free sensed data”. Shelton then offers different solutions to the problem of suboptimal control using other sensed information upon which the control system can act to adjust the parameters (¶1056). “In one exemplification, the surgical hub 5104 can incorporate a situational awareness system, which is the hardware and/or programming associated with the surgical hub 5104 that derives contextual information pertaining to the surgical procedure from the received data.” (¶1056).
At ¶1057, Shelton teaches that “[i]n response to a query with one or more inputs, the lookup table can return the corresponding contextual information for the situational awareness system for controlling the modular devices 5102. In one exemplification, the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.”
At ¶1059, Shelton teaches “the type of tissue being operated can affect the adjustments that are made to the compression rate and load thresholds of a surgical stapling and cutting instrument for a particular tissue gap measurement. A situationally aware surgical hub 5104 could infer whether a surgical procedure being performed is a thoracic or an abdominal procedure, allowing the surgical hub 5104 to determine whether the tissue clamped by an end effector of the surgical stapling and cutting instrument is lung (for a thoracic procedure) or stomach (for an abdominal procedure) tissue. The surgical hub 5104 could then adjust the compression rate and load thresholds of the surgical stapling and cutting instrument appropriately for the type of tissue.”
At ¶1062, Shelton teaches “data can be drawn from additional data sources 5126 to improve the conclusions that the surgical hub 5104 draws from one data source 5126. A situationally aware surgical hub 5104 could augment data that it receives from the modular devices 5102 with contextual information that it has built up regarding the surgical procedure from other data sources 5126.”
At ¶1066, Shelton teaches “the surgical hub 5104 can be configured to compare the list of items for the procedure (scanned by the scanner 5132 depicted in FIG.85B, for example).
At ¶1070, Shelton teaches “[t]the control circuit of the surgical hub 5104 executing the process 5000a receives 5004a data from one or more data sources 5126 to which the surgical hub 5104 is communicably connected. The data sources 5126 include, for example, databases 5122, patient monitoring devices 5124, and modular devices 5102.”
At ¶1072, Shelton expressly teaches how the surgical system control circuit can then determine 5008a what control adjustments are necessary (if any) for one or more modular devices 5102 according to the derived 5006a contextual information. After determining 5008a the control adjustments, the control circuit of the surgical hub 5104 can then control 5010a the modular devices according to the control adjustments (if the control circuit determined 5008a that any were necessary)…. The control circuit can control 5010a the modular devices 5102 according to the determined 5008a control adjustment by, for example, transmitting the control adjustments to the particular modular device to update the modular device's 5102 programming. In another exemplification wherein the modular device(s) 5102 and the surgical hub 5104 are executing a distributed computing architecture, the control circuit can control 5010a the modular device 5102 according to the determined 5008a control adjustments by updating the distributed program.”
In these paragraphs, Shelton describes a very detailed surgical hub situational awareness system. The scope, breadth, interaction, and complexity of the system is large, but finite. A person of ordinary skill in the art looking to solve the problem of how to situationally account for and adjust items by their stages of useable life would necessarily look to the teachings of Shelton. One among many reasons is that Shelton expressly incorporates by reference US Patent Application Publication 20160249917, titled SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER, which published on Sep. 1, 2016 (¶1675). A person of ordinary skill in the art seeking to learn more about tracking an end-of-life parameter, such as adjustment information, would necessarily be drawn to the work of Shelton through a gateway publication to an consider a situational awareness hub as an storage device component for a surgical system that includes instrument useable life parameters. Such a connection is one of common parallel and follow-on engineering practices by the same inventor, rather than hindsight.
Additionally, Shelton works through the different aspects of the system using various examples, but all of these examples are interrelated as part of the same situational awareness system. The disclosure is voluminous, but fairly comprehensive in its treatment of the subject matter of the situational awareness hub and the working interrelationship of its hardware, software, and data structure and retrieval systems.
At ¶1651, Shelton provides express examples of triggered requests by the system for additional data and teaches “the push request could cause the surgical hub 7006 to obtain additional data for a specific predetermined time period, such as three months. The time period could be based on an estimated remaining useful life of the surgical instrument 7012, for example.”
At ¶1678, Shelton explains that the situational awareness data for end of life parameters is important because “the cloud-based system 105 may be configured to create a list of inventory items not authorized to perform surgical procedures due to one or more system-defined constraints. In one exemplification, after input of a desired surgical procedure(s) by an institution into its cloud interface (e.g. FIG. 202), the cloud-based system 105 may determine that one or more inventory items of the institution (e.g., detected by and associated with and/or needed to perform the input surgical procedure(s)) are not authorized to perform the input surgical procedure(s) based on system-defined constraints. In such an exemplification, it may be determined that an identifier (e.g., serial number, unique ID, etc.) associated with an inventory item is not authorized to perform the input surgical procedure(s) (e.g., inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.”
Based on the discussions of record and the foregoing, the rejection is maintained.
Claim Rejections Maintained and Modified – Necessitated by Amendment
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-10 and 18-20 remain rejected and new claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Weir et al., US 20180161052 (14 June 2018), in view of Shelton et al., US 20190125458 (2 May 2019).
Regarding currently amended independent claim 1, Weir teaches a surgical system (FIG 1, ¶27, computer assisted system 100; FIG 2, ¶33, surgical instrument 200), comprising:
at least one input coupler configured to receive an input (FIG 2, ¶36 “surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210. Drive system 240 includes one or more components for introducing forces and/or torques to surgical instrument 200 that may be used to manipulate the various DOF supported by the surgical instrument 200”);
an instrument (FIG 2, ¶33, surgical instrument 200) including an end effector assembly having a pair of jaw members configured to grasp tissue (FIG 2, ¶34, end effector 220 is generally consistent with a two-jawed gripper-style end effector);
an actuation assembly operably coupled between the at least one input coupler and the end effector assembly (FIGs 2, 3, ¶37, drive mechanisms 250) such that, in response to receipt of the input by the at least one input coupler, the pair of jaw members is caused to transition from an open position to a closed position (FIG 3, ¶43 “a distal end of two of the drive mechanisms 250 (one for each of jaws 310) may be coupled to a respective jaw 310 so that as the corresponding drive mechanism 250 applies a pull and/or a pushing force (for example, using a cable, lead screw, and/or the like”), the respective jaw 310 may be opened and/or closed) to apply a jaw force to tissue disposed between the pair of jaw members (FIG 3, ¶73, articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest);
an articulating section operably coupled between the least one input coupler and the end effector assembly (FIG 3, ¶47, articulated wrist 230);, the articulating section configured to transition the end effector assembly between an un-articulated position and at least one articulated position (FIGs 3, 4A-4C, ¶47 “a cutting operation may be accomplished by teleoperating an articulated arm to place end effector 220 in proximity to the tissue of interest. Articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest”); and
a storage device storing setting information and adjustment information (FIG 1, ¶29, Control unit 140 includes a processor 150 coupled to memory 160; ¶76), the setting information enabling determination of a first input to the at least one input coupler to cause the pair of jaw members to apply the jaw force to the tissue (FIG 9, ¶66, “at process 910, jaws of a surgical instrument are operated. … In some examples, the jaws may be operated to control their position and/or orientation as well as to adjust an angle between the jaws”), and the adjustment information enabling adjustment of the setting information from a basis jaw drive setting to an adjusted jaw drive setting based on a characteristic of the instrument (FIG 9, ¶69, “at process 940, wrist articulation is measured. In some examples, the wrist articulation may be measured using one of more position and/or rotation sensors. In some examples, the sensors may be located proximal to the articulated wrist and may be configured to measure each of the articulation angles, such as pitch and/or yaw”) for determination of a second input to the at least one input coupler to cause the pair of jaw members to apply the jaw force to the tissue (FIG 9, ¶70 “at a process 950, the jaw angle is corrected based on the wrist articulation. Using the jaw angle measured during process 930 and the wrist articulation measured during process 940, a corrected value for the jaw angle may be determined by the control application; ¶71, “at process 960, the cutting operation is restricted based on the corrected jaw angle”; see also, ¶31 and claims 45-54).
Weir does not teach wherein the characteristic of the instrument includes a stage of usable life of the instrument.
In addition to the above, Weir expressly teaches that the angle of the jaws may be adjusted and oriented “as desired” (¶66). Weir also teaches that the correct jaw angle of the instrument is configured to adjust the measured jaw angle based on a correction model (claims 47, 49, 57, and 59). Weir teaches that coefficients for measured jaw angles “may be modeled over a collection of surgical instruments or individually for each surgical instrument, with the coefficient values being recorded so that they are able to be accessed at run time based on an identifier, such as a serial number, of the corresponding surgical instrument” (¶64). See also, ¶70. FIG 8 of Weir also shows the data of scatter plot 800 which was matched to various models to determine a suitable model for the relationship and/or function between the actual jaw angle and measured jaw angle as pitch and yaw angle are varied (¶63).
Shelton teaches surgical robotic systems including FIG 204, which illustrates a surgical tool including modular components wherein the status of each modular component is evaluated based on system-defined constraints (¶259). “FIG 204 illustrates an example multi-component surgical tool (e.g., a wireless surgical device/instrument 235) comprising a plurality of modular components handle 8204, modular adapter 8206, end effector 8208 (comprising jaws), staple cartridge 8210, wherein each modular component is associated with an identifier 8214, 8216, 8218, 8220 respectively (e.g., a serial number)” (¶1681).
At ¶1057, Shelton teaches that “[i]n response to a query with one or more inputs, the lookup table can return the corresponding contextual information for the situational awareness system for controlling the modular devices 5102. In one exemplification, the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.”
At ¶1059, Shelton teaches “the type of tissue being operated can affect the adjustments that are made to the compression rate and load thresholds of a surgical stapling and cutting instrument for a particular tissue gap measurement. A situationally aware surgical hub 5104 could infer whether a surgical procedure being performed is a thoracic or an abdominal procedure, allowing the surgical hub 5104 to determine whether the tissue clamped by an end effector of the surgical stapling and cutting instrument is lung (for a thoracic procedure) or stomach (for an abdominal procedure) tissue. The surgical hub 5104 could then adjust the compression rate and load thresholds of the surgical stapling and cutting instrument appropriately for the type of tissue.”
At ¶1062, Shelton teaches “data can be drawn from additional data sources 5126 to improve the conclusions that the surgical hub 5104 draws from one data source 5126. A situationally aware surgical hub 5104 could augment data that it receives from the modular devices 5102 with contextual information that it has built up regarding the surgical procedure from other data sources 5126.”
At ¶1066, Shelton teaches “the surgical hub 5104 can be configured to compare the list of items for the procedure (scanned by the scanner 5132 depicted in FIG.85B, for example).
At ¶1070, Shelton teaches “[t]the control circuit of the surgical hub 5104 executing the process 5000a receives 5004a data from one or more data sources 5126 to which the surgical hub 5104 is communicably connected. The data sources 5126 include, for example, databases 5122, patient monitoring devices 5124, and modular devices 5102.”
At ¶1072, Shelton expressly teaches how the surgical system control circuit can then determine 5008a what control adjustments are necessary (if any) for one or more modular devices 5102 according to the derived 5006a contextual information. After determining 5008a the control adjustments, the control circuit of the surgical hub 5104 can then control 5010a the modular devices according to the control adjustments (if the control circuit determined 5008a that any were necessary)…. The control circuit can control 5010a the modular devices 5102 according to the determined 5008a control adjustment by, for example, transmitting the control adjustments to the particular modular device to update the modular device's 5102 programming. In another exemplification wherein the modular device(s) 5102 and the surgical hub 5104 are executing a distributed computing architecture, the control circuit can control 5010a the modular device 5102 according to the determined 5008a control adjustments by updating the distributed program.”
At ¶1651, Shelton provides express examples of triggered requests by the system for additional data and teaches “the push request could cause the surgical hub 7006 to obtain additional data for a specific predetermined time period, such as three months. The time period could be based on an estimated remaining useful life of the surgical instrument 7012, for example.”
At ¶1678, Shelton explains that the situational awareness data for end of life parameters is important because “the cloud-based system 105 may be configured to create a list of inventory items not authorized to perform surgical procedures due to one or more system-defined constraints. In one exemplification, after input of a desired surgical procedure(s) by an institution into its cloud interface (e.g. FIG. 202), the cloud-based system 105 may determine that one or more inventory items of the institution (e.g., detected by and associated with and/or needed to perform the input surgical procedure(s)) are not authorized to perform the input surgical procedure(s) based on system-defined constraints. In such an exemplification, it may be determined that an identifier (e.g., serial number, unique ID, etc.) associated with an inventory item is not authorized to perform the input surgical procedure(s) (e.g., inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.”
At ¶1682, Shelton teaches “the memory unit of each modular component [broadly read as a storage device] may be configured to store more than its identifier. In one aspect of the present disclosure, each modular component (e.g., 8204, 8206, 8208, 8210, etc.) may further comprise a counter (not shown) configured to track a usage parameter of the modular component and its memory unit may be configured to store that usage parameter. In another aspect, the memory unit of each respective modular component may be further configured to store a usable life metric. Such a usable life metric may be stored during manufacture of the modular component. For example, in view of FIG 204, the memory unit of the handle 8204 may store both the usage parameter (e.g., 235) and the usable life metric (e.g., 400). In such an aspect, the handle 8204 has been used 235 times out of its usable life of 400 uses. Similarly, in view of FIG 204, the modular adapter has been used 103 times out of its usable life of 100 uses, and the end effector has been used 5 times out of its usable life of 12 uses.”
At ¶1682, Shelton continues, teaching “[h]ere, similar to above, once a communication link is established with the surgical hub 106, the identifier, usage parameter and/or usable life metric stored in the memory unit of each modular component may be transmitted directly from each modular component to the surgical hub 106 or indirectly via another modular component. In addition, similar to above, the same form or different forms of wired/wireless communication may be used. In one aspect, once the surgical hub 106 has received all identifiers for all modular components, the surgical hub 106 may transmit the identifiers to the cloud-based analytics system (e.g., comprising cloud-based system 105).”
At ¶1684, Shelton teaches “in aspects where the memory unit of each modular component stores its usage parameter and/or usable life metric, the surgical hub 106 may also store/track the usage parameter and/or usable life metric associated with each modular component in its inventory. In such an example, if a usage parameter and/or a usable life metric transmitted from a modular component differs from a usage parameter and/or a usable life metric stored/tracked at the surgical hub 106, the surgical hub 106 may flag the discrepancy and modify the status of that modular component (e.g., to unavailable, to unauthorized, to unusable, etc.).”
At ¶1568, Shelton teaches “the cloud system may also be configured for intentional deployment of control algorithms to devices with an in-use criteria meeting specific criteria. For regional differences, the cloud system may adjust the control algorithms of various surgical devices. A different amount of force may be applied to a device for patients in a different demographic, for example. As another example, surgeons may have different uses for a type of surgical device, and control algorithms can be adjusted to account for this. The cloud system may be configured to send out a wide area update to a device, and may target the regional and specific instrument IDs which allow for targeted updates to their control programs.”
At ¶1678, Shelton teaches “the cloud-based system 105 may determine that one or more inventory items of the institution (e.g., detected by and associated with and/or needed to perform the input surgical procedure(s)) are not authorized to perform the input surgical procedure(s) based on system-defined constraints. In such an exemplification, it may be determined that an identifier (e.g., serial number, unique ID, etc.) associated with an inventory item is not authorized to perform the input surgical procedure(s) (e.g., inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.). In one example, the institution's cloud interface may display an inventory item in association with its unauthorized status 8114. In such an aspect, the cloud interface may further display a warning or alert regarding the unauthorized status (e.g., highlighting, blacked out, etc.). Such a warning or alert may indicate that the surgical procedure(s) input at the cloud interface cannot be performed based on current inventory items. In one aspect, a same or similar warning or alert may be communicated to the inventory item itself for display on a user interface of the inventory item itself (e.g., a user interface of Handle D). Similar to above, the cloud interface 8104 may display available alternatives to the unauthorized inventory item (e.g., Handle B).”
At ¶1687, Shelton teaches “[s]ystem-defined constraints, similar to the usable life metric, may be associated with the identifier of each modular component. For example, a system-defined constraint associated with a modular component may include an expiration date, a requirement that an identifier (e.g., serial number) is a system-recognizable identifier (e.g., not counterfeit), and/or flexible system-defined constraints (e.g., constraints deemed non-critical until a threshold is met and the constraint is deemed critical). In one aspect of the present disclosure, if one system-defined constraint is not met, a modular component (e.g., 8204, 8206, 8208, 8210, etc.) may be deemed unavailable/unusable/unauthorized despite being available/usable/authorized based on other system-defined constraint(s) (e.g., having remaining usable life). In various aspects, one or more predetermined system-defined constraints are non-critical system-defined constraints. Such non-critical system-defined constraints may be waived (see FIG. 204, e.g., 8274, manual override) to render the modular component available/usable/authorized and/or may produce in a warning indicator/message (see FIG. 204, e.g., 8244). Critical system-defined constraints cannot be waived.”
Additionally, Shelton teaches “the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input”(¶1057).
Weir and Shelton teach in the same field of endeavor, robotic surgical instruments comprising end effectors with jaws, actuation assemblies, storage devices for storing, setting, and adjusting information (processors, memory, and algorithms). Shelton teaches instrument adjustment characteristics where the instrument includes a stage of usable life of the instrument. Shelton provides various rationales as to instrument comprising the stage of usable life. Shelton also teaches situations in which a manual override to render the modular component available/usable/authorized may be possible. Weir teaches multiple adjustment and correction mechanisms of the end effector (e.g. instrument comprising jaws; see Shelton FIG 204, end effector 8208) such that corrective adjustments as to the angle, position, or use of the end effector may be undertaken “as desired” (Weir at ¶66). Weir teaches the storage device comprising instrument adjustments based on an identifier, such as a serial number.
Shelton teaches that many characteristics, including a stage of usable life of the instrument may be ascertained by the identification of the instrument and according to its serial number and that a database of detailed information can be correlated among aggregated data (¶1658) and the adjustments made according to derived inferences (¶¶1771, 1772). Shelton teaches that surgical tools can be adjusted based on sensed conditions (¶1889) or based on the proximity of the tool to a visually-detectable need and/or the situational awareness of the system (¶1891). See also ¶1057 “the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.”
Shelton describes a very detailed surgical hub situational awareness system. The scope, breadth, interaction, and complexity of the system is large, but finite. A person of ordinary skill in the art looking to solve the problem of how to situationally account for and adjust items by their stages of useable life would necessarily look to the teachings of Shelton. Shelton expressly incorporates by reference US Patent Application Publication 20160249917, titled SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER, which published on Sep. 1, 2016 (¶1675). A person of ordinary skill in the art seeking to learn more about tracking an end-of-life parameter, such as adjustment information, would necessarily be drawn to the work of Shelton through a gateway publication to an consider a situational awareness hub as an storage device component for a surgical system that includes instrument useable life parameters.
Additionally, Shelton works through the different aspects of the system using various examples, but all of these examples are interrelated as part of the same situational awareness system. The disclosure is voluminous, but fairly comprehensive in its treatment of the subject matter of the situational awareness hub and the working interrelationship of its hardware, software, and data structure and retrieval systems.
At ¶1651, Shelton provides express examples of triggered requests by the system for additional data and teaches “the push request could cause the surgical hub 7006 to obtain additional data for a specific predetermined time period, such as three months. The time period could be based on an estimated remaining useful life of the surgical instrument 7012, for example.”
Because Shelton’s situational awareness hub includes all of the same components as the surgical system of Weir, a person of ordinary skill in the art, seeking to control and coordinate the interrelated components would look to a storage device system capable of orchestrating the complexities of the surgical system. Additionally, a person of ordinary skill in the art would consulting Shelton’s situationally aware hub solution would reasonably apprised of how to solve the problem of how to situationally account for and adjust items by their stages of useable life by in light of Shelton’s incorporation by reference of US Patent Application Publication 20160249917 (¶1675). A person of ordinary skill in the art seeking to learn more about tracking an end-of-life parameter, such as adjustment information, would necessarily be drawn to the work of Shelton through a gateway publication to an consider a situational awareness hub as an storage device component and be apprised that the surgical system hub is capable of encompassing all kinds of data, expressly including useable life parameters of the surgical instruments in order to make adjustments as necessary (¶¶1057, 1687).
Because the references address the same engineering problem (surgical systems comprising input couplers, end effectors comprising jaws, actuation assemblies, articulation components, and storage devices storing functional information and settings) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding the hub components and databases to existing surgical systems), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 2, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches wherein the adjustment information is based on the at least one articulated position of the end effector assembly (FIG 9, ¶70, At a process 950, the jaw angle is corrected based on the wrist articulation).
Regarding claim 3, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches wherein the second input is different than the first input (FIG 8, movement; claim 46, cutting operation: extension, retraction).
Regarding claim 4, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches wherein the adjustment information includes an articulation angle of the articulating section and a corresponding rotational input to be received by the at least one input coupler as the second input (FIG 9, ¶69 “process 940, wrist articulation is measured. In some examples, the wrist articulation may be measured using one of more position and/or rotation sensors. In some examples, the sensors may be located proximal to the articulated wrist and may be configured to measure each of the articulation angles, such as pitch and/or yaw; FIG 8, scatter plot showing x, y, z axes”).
Regarding claim 5, Weir modified by Shelton teaches the surgical system according to claim 4, as set forth above.
Weir teaches wherein the articulation angle of the articulating section includes at least one of a pitch angle of the articulating section or a yaw angle of the articulating section (FIG 8, scatter plot, x, y, z axes; ¶¶62-64).
Regarding claim 6, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches wherein the at least one input coupler is configured to receive a rotational input as the input and to rotate in response thereto (FIG 5, ¶44, drive unit 500 is based on a rotational actuation approach in which a capstan 510 is rotated to actuate a DOF).
Regarding claim 7, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches further comprising at least one motor configured to provide the input to the at least one input coupler (FIG 5, ¶44).
Regarding claim 8, Weir modified by Shelton teaches the surgical system according to claim 7, as set forth above.
Weir teaches further comprising a control device (FIG 1 , control unit 140; ¶27, computer assisted device 110) configured to access the setting information and the adjustment information and control the motor (¶73, motor) based thereon to provide the first input or the second input to cause the pair of jaw members to apply the jaw force to the tissue (FIG 2, ¶36, “surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210. Drive system 240 includes one or more components for introducing forces and/or torques to surgical instrument 200 that may be used to manipulate the various DOF supported by the surgical instrument 200; FIG 9, At a process 960, the cutting operation is restricted based on the corrected jaw angle. In some examples, the corrected jaw angle as determined during process 950 may be combined with a configurable tolerance for blade exposures to determine whether the cutting operation is to be restricted; ¶73, articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest”).
Regarding claim 9, Weir modified by Shelton teaches the surgical system according to claim 8, as set forth above.
Weir teaches wherein the control device (FIG 1; ¶76 “control unit 140 may include non-transient, tangible, machine readable media that include executable code that when run by one or more processors (e.g., processor 150) may cause the one or more processors to perform the processes of method 900”) is configured to access the position of the end effector assembly and to control the motor based on the setting information, the adjustment information, and the position of the end effector assembly to provide the first input or the second input to cause the pair of jaw members to apply the jaw force to the tissue (FIG 2, ¶36, “surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210. Drive system 240 includes one or more components for introducing forces and/or torques to surgical instrument 200 that may be used to manipulate the various DOF supported by the surgical instrument 200”; FIG 9, At a process 960, the cutting operation is restricted based on the corrected jaw angle. In some examples, the corrected jaw angle as determined during process 950 may be combined with a configurable tolerance for blade exposures to determine whether the cutting operation is to be restricted; ¶73 “articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest”).
Regarding claim 10, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Weir teaches, further comprising: a robotic surgical system, including:
a robot arm including at least one operable interface configured to provide an input (¶28, “computer-assisted device 110 may further be coupled to an operator workstation (not shown), which may include one or more master controls for operating the computer-assisted device 110, the one or more articulated arms 120, and/or the instruments 130”);
at least one motor (FIG 1, ¶36); and
a control device configured to control the at least one motor to provide the input to the at least one operable interface (FIG 1, ¶29, Control unit 140 includes a processor 150 coupled to memory 160).
Regarding independent claim 18, Weir teaches a surgical system (FIG 1, ¶27, computer assisted system 100; FIG 2, ¶33, surgical instrument 200), comprising:
a robotic surgical system (FIG 1, ¶27 computer assisted system 100), including:
a robot arm including at least one operable interface configured to provide an input (¶28);
at least one motor (FIG 1, ¶36, surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210 … drive system 240 may include one or more motors); and
a control device configured to control the at least one motor to provide the input to the at least one operable interface (FIG 1, ¶29, Control unit 140 includes a processor 150 coupled to memory 160);
a surgical instrument (FIG 2, ¶36, surgical instrument 200), including:
at least one input coupler configured to operably couple with the at least one operable interface to receive the input therefrom (FIG 2, ¶36 “surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210. Drive system 240 includes one or more components for introducing forces and/or torques to surgical instrument 200 that may be used to manipulate the various DOF supported by the surgical instrument 200”);
an end effector assembly having a pair of jaw members configured to grasp tissue (FIG 2, ¶34, end effector 220 is generally consistent with a two-jawed gripper-style end effector);
an actuation assembly operably coupled between the at least one input coupler and the end effector assembly (FIGs 2, 3, ¶37, drive mechanisms 250) such that, in response receipt of the input by the at least one input coupler, the pair of jaw members is caused to transition from an open position to a closed position (FIG 3, ¶43 “a distal end of two of the drive mechanisms 250 (one for each of jaws 310) may be coupled to a respective jaw 310 so that as the corresponding drive mechanism 250 applies a pull and/or a pushing force (for example, using a cable, lead screw, and/or the like”), the respective jaw 310 may be opened and/or closed) to achieve a desired jaw force applied by the pair of jaw members to tissue disposed between the pair of jaw members (FIG 3, ¶73, articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest);
an articulating section operably coupled between the least one input coupler and the end effector assembly (FIG 3, ¶73, articulated wrist 230), the articulating section configured to transition the end effector assembly between an un-articulated position and at least one articulated position (FIGs 3, 4A-4C, ¶47 “a cutting operation may be accomplished by teleoperating an articulated arm to place end effector 220 in proximity to the tissue of interest. Articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest”); and
a storage device storing setting information and adjustment information (¶76, “machine readable media and/or any other medium from which a processor or computer is adapted to read”), wherein the control device is configured to access the setting information and the adjustment information and determine, based on the position of the end effector assembly (FIG 9, ¶69, “process 940, wrist articulation is measured. In some examples, the wrist articulation may be measured using one of more position and/or rotation sensors. In some examples, the sensors may be located proximal to the articulated wrist and may be configured to measure each of the articulation angles, such as pitch and/or yaw”), whether to utilize the setting information to control the at least one motor to provide a first input to the at least one operable interface to achieve the desired jaw force or to adjust the setting information based on the adjustment information to control the at least one motor to provide a second, different input to the at least one operable interface to achieve the desired jaw force (FIGs 2, 9, ¶36 “surgical instrument 200 further includes a drive system 240 located at the proximal end of shaft 210. Drive system 240 includes one or more components for introducing forces and/or torques to surgical instrument 200 that may be used to manipulate the various DOF supported by the surgical instrument 200”; ¶73, “articulated wrist 230 and jaws 310 may then be used to grasp the tissue of interest”; ¶31; claims 45-54), wherein the adjustment information enables an adjustment of the setting information from a basis jaw drive setting to an adjusted jaw drive setting based on a characteristic of the surgical instrument (FIG 9, ¶70 “process 950, the jaw angle is corrected based on the wrist articulation. Using the jaw angle measured during process 930 and the wrist articulation measured during process 940, a corrected value for the jaw angle may be determined by the control application”; ¶71 “process 960, the cutting operation is restricted based on the corrected jaw angle”; ¶31; claims 45-54).
Weir does not teach wherein the characteristic of the instrument includes a stage of usable life of the instrument.
In addition to the above, Weir expressly teaches that the angle of the jaws may be adjusted and oriented “as desired” (¶66). Weir also teaches that the correct jaw angle of the instrument is configured to adjust the measured jaw angle based on a correction model (claims 47, 49, 57, and 59). Weir teaches that coefficients for measured jaw angles “may be modeled over a collection of surgical instruments or individually for each surgical instrument, with the coefficient values being recorded so that they are able to be accessed at run time based on an identifier, such as a serial number, of the corresponding surgical instrument” (¶64). See also, ¶70. FIG 8 of Weir also shows the data of scatter plot 800 which was matched to various models to determine a suitable model for the relationship and/or function between the actual jaw angle and measured jaw angle as pitch and yaw angle are varied (¶63).
Shelton teaches surgical robotic systems including FIG 204, which illustrates a surgical tool including modular components wherein the status of each modular component is evaluated based on system-defined constraints (¶259). “FIG 204 illustrates an example multi-component surgical tool (e.g., a wireless surgical device/instrument 235) comprising a plurality of modular components handle 8204, modular adapter 8206, end effector 8208 (comprising jaws), staple cartridge 8210, wherein each modular component is associated with an identifier 8214, 8216, 8218, 8220 respectively (e.g., a serial number)” (¶1681).
At ¶1057, Shelton teaches that “[i]n response to a query with one or more inputs, the lookup table can return the corresponding contextual information for the situational awareness system for controlling the modular devices 5102. In one exemplification, the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.”
At ¶1059, Shelton teaches “the type of tissue being operated can affect the adjustments that are made to the compression rate and load thresholds of a surgical stapling and cutting instrument for a particular tissue gap measurement. A situationally aware surgical hub 5104 could infer whether a surgical procedure being performed is a thoracic or an abdominal procedure, allowing the surgical hub 5104 to determine whether the tissue clamped by an end effector of the surgical stapling and cutting instrument is lung (for a thoracic procedure) or stomach (for an abdominal procedure) tissue. The surgical hub 5104 could then adjust the compression rate and load thresholds of the surgical stapling and cutting instrument appropriately for the type of tissue.”
At ¶1062, Shelton teaches “data can be drawn from additional data sources 5126 to improve the conclusions that the surgical hub 5104 draws from one data source 5126. A situationally aware surgical hub 5104 could augment data that it receives from the modular devices 5102 with contextual information that it has built up regarding the surgical procedure from other data sources 5126.”
At ¶1066, Shelton teaches “the surgical hub 5104 can be configured to compare the list of items for the procedure (scanned by the scanner 5132 depicted in FIG.85B, for example).
At ¶1070, Shelton teaches “[t]the control circuit of the surgical hub 5104 executing the process 5000a receives 5004a data from one or more data sources 5126 to which the surgical hub 5104 is communicably connected. The data sources 5126 include, for example, databases 5122, patient monitoring devices 5124, and modular devices 5102.”
At ¶1072, Shelton expressly teaches how the surgical system control circuit can then determine 5008a what control adjustments are necessary (if any) for one or more modular devices 5102 according to the derived 5006a contextual information. After determining 5008a the control adjustments, the control circuit of the surgical hub 5104 can then control 5010a the modular devices according to the control adjustments (if the control circuit determined 5008a that any were necessary)…. The control circuit can control 5010a the modular devices 5102 according to the determined 5008a control adjustment by, for example, transmitting the control adjustments to the particular modular device to update the modular device's 5102 programming. In another exemplification wherein the modular device(s) 5102 and the surgical hub 5104 are executing a distributed computing architecture, the control circuit can control 5010a the modular device 5102 according to the determined 5008a control adjustments by updating the distributed program.”
At ¶1651, Shelton provides express examples of triggered requests by the system for additional data and teaches “the push request could cause the surgical hub 7006 to obtain additional data for a specific predetermined time period, such as three months. The time period could be based on an estimated remaining useful life of the surgical instrument 7012, for example.”
At ¶1678, Shelton explains that the situational awareness data for end of life parameters is important because “the cloud-based system 105 may be configured to create a list of inventory items not authorized to perform surgical procedures due to one or more system-defined constraints. In one exemplification, after input of a desired surgical procedure(s) by an institution into its cloud interface (e.g. FIG. 202), the cloud-based system 105 may determine that one or more inventory items of the institution (e.g., detected by and associated with and/or needed to perform the input surgical procedure(s)) are not authorized to perform the input surgical procedure(s) based on system-defined constraints. In such an exemplification, it may be determined that an identifier (e.g., serial number, unique ID, etc.) associated with an inventory item is not authorized to perform the input surgical procedure(s) (e.g., inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.”
At ¶1682, Shelton teaches “the memory unit of each modular component [broadly read as a storage device] may be configured to store more than its identifier. In one aspect of the present disclosure, each modular component (e.g., 8204, 8206, 8208, 8210, etc.) may further comprise a counter (not shown) configured to track a usage parameter of the modular component and its memory unit may be configured to store that usage parameter. In another aspect, the memory unit of each respective modular component may be further configured to store a usable life metric. Such a usable life metric may be stored during manufacture of the modular component. For example, in view of FIG 204, the memory unit of the handle 8204 may store both the usage parameter (e.g., 235) and the usable life metric (e.g., 400). In such an aspect, the handle 8204 has been used 235 times out of its usable life of 400 uses. Similarly, in view of FIG 204, the modular adapter has been used 103 times out of its usable life of 100 uses, and the end effector has been used 5 times out of its usable life of 12 uses.”
At ¶1682, Shelton continues, teaching “[h]ere, similar to above, once a communication link is established with the surgical hub 106, the identifier, usage parameter and/or usable life metric stored in the memory unit of each modular component may be transmitted directly from each modular component to the surgical hub 106 or indirectly via another modular component. In addition, similar to above, the same form or different forms of wired/wireless communication may be used. In one aspect, once the surgical hub 106 has received all identifiers for all modular components, the surgical hub 106 may transmit the identifiers to the cloud-based analytics system (e.g., comprising cloud-based system 105).”
At ¶1684, Shelton teaches “in aspects where the memory unit of each modular component stores its usage parameter and/or usable life metric, the surgical hub 106 may also store/track the usage parameter and/or usable life metric associated with each modular component in its inventory. In such an example, if a usage parameter and/or a usable life metric transmitted from a modular component differs from a usage parameter and/or a usable life metric stored/tracked at the surgical hub 106, the surgical hub 106 may flag the discrepancy and modify the status of that modular component (e.g., to unavailable, to unauthorized, to unusable, etc.).”
At ¶1568, Shelton teaches “the cloud system may also be configured for intentional deployment of control algorithms to devices with an in-use criteria meeting specific criteria. For regional differences, the cloud system may adjust the control algorithms of various surgical devices. A different amount of force may be applied to a device for patients in a different demographic, for example. As another example, surgeons may have different uses for a type of surgical device, and control algorithms can be adjusted to account for this. The cloud system may be configured to send out a wide area update to a device, and may target the regional and specific instrument IDs which allow for targeted updates to their control programs.”
At ¶1678, Shelton teaches “the cloud-based system 105 may determine that one or more inventory items of the institution (e.g., detected by and associated with and/or needed to perform the input surgical procedure(s)) are not authorized to perform the input surgical procedure(s) based on system-defined constraints. In such an exemplification, it may be determined that an identifier (e.g., serial number, unique ID, etc.) associated with an inventory item is not authorized to perform the input surgical procedure(s) (e.g., inventory item exceeds usable life, inventory item is counterfeit, inventory item is defective, etc.). In one example, the institution's cloud interface may display an inventory item in association with its unauthorized status 8114. In such an aspect, the cloud interface may further display a warning or alert regarding the unauthorized status (e.g., highlighting, blacked out, etc.). Such a warning or alert may indicate that the surgical procedure(s) input at the cloud interface cannot be performed based on current inventory items. In one aspect, a same or similar warning or alert may be communicated to the inventory item itself for display on a user interface of the inventory item itself (e.g., a user interface of Handle D). Similar to above, the cloud interface 8104 may display available alternatives to the unauthorized inventory item (e.g., Handle B).”
At ¶1687, Shelton teaches “[s]ystem-defined constraints, similar to the usable life metric, may be associated with the identifier of each modular component. For example, a system-defined constraint associated with a modular component may include an expiration date, a requirement that an identifier (e.g., serial number) is a system-recognizable identifier (e.g., not counterfeit), and/or flexible system-defined constraints (e.g., constraints deemed non-critical until a threshold is met and the constraint is deemed critical). In one aspect of the present disclosure, if one system-defined constraint is not met, a modular component (e.g., 8204, 8206, 8208, 8210, etc.) may be deemed unavailable/unusable/unauthorized despite being available/usable/authorized based on other system-defined constraint(s) (e.g., having remaining usable life). In various aspects, one or more predetermined system-defined constraints are non-critical system-defined constraints. Such non-critical system-defined constraints may be waived (see FIG. 204, e.g., 8274, manual override) to render the modular component available/usable/authorized and/or may produce in a warning indicator/message (see FIG. 204, e.g., 8244). Critical system-defined constraints cannot be waived.”
Additionally, Shelton teaches “the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input”(¶1057).
Weir and Shelton teach in the same field of endeavor, robotic surgical instruments comprising end effectors with jaws, actuation assemblies, storage devices for storing, setting, and adjusting information (processors, memory, and algorithms). Shelton teaches instrument adjustment characteristics where the instrument includes a stage of usable life of the instrument. Shelton provides various rationales as to instrument comprising the stage of usable life. Shelton also teaches situations in which a manual override to render the modular component available/usable/authorized may be possible. Weir teaches multiple adjustment and correction mechanisms of the end effector (e.g. instrument comprising jaws; see Shelton FIG 204, end effector 8208) such that corrective adjustments as to the angle, position, or use of the end effector may be undertaken “as desired” (Weir at ¶66). Weir teaches the storage device comprising instrument adjustments based on an identifier, such as a serial number.
Shelton teaches that many characteristics, including a stage of usable life of the instrument may be ascertained by the identification of the instrument and according to its serial number and that a database of detailed information can be correlated among aggregated data (¶1658) and the adjustments made according to derived inferences (¶¶1771, 1772). Shelton teaches that surgical tools can be adjusted based on sensed conditions (¶1889) or based on the proximity of the tool to a visually-detectable need and/or the situational awareness of the system (¶1891). See also ¶1057 “the contextual information received by the situational awareness system of the surgical hub 5104 is associated with a particular control adjustment or set of control adjustments for one or more modular devices 5102. In another exemplification, the situational awareness system includes a further machine learning system, lookup table, or other such system, which generates or retrieves one or more control adjustments for one or more modular devices 5102 when provided the contextual information as input.”
Shelton describes a very detailed surgical hub situational awareness system. The scope, breadth, interaction, and complexity of the system is large, but finite. A person of ordinary skill in the art looking to solve the problem of how to situationally account for and adjust items by their stages of useable life would necessarily look to the teachings of Shelton. Shelton expressly incorporates by reference US Patent Application Publication 20160249917, titled SURGICAL APPARATUS CONFIGURED TO TRACK AN END-OF-LIFE PARAMETER, which published on Sep. 1, 2016 (¶1675). A person of ordinary skill in the art seeking to learn more about tracking an end-of-life parameter, such as adjustment information, would necessarily be drawn to the work of Shelton through a gateway publication to an consider a situational awareness hub as an storage device component for a surgical system that includes instrument useable life parameters.
Additionally, Shelton works through the different aspects of the system using various examples, but all of these examples are interrelated as part of the same situational awareness system. The disclosure is voluminous, but fairly comprehensive in its treatment of the subject matter of the situational awareness hub and the working interrelationship of its hardware, software, and data structure and retrieval systems.
At ¶1651, Shelton provides express examples of triggered requests by the system for additional data and teaches “the push request could cause the surgical hub 7006 to obtain additional data for a specific predetermined time period, such as three months. The time period could be based on an estimated remaining useful life of the surgical instrument 7012, for example.”
Because Shelton’s situational awareness hub includes all of the same components as the surgical system of Weir, a person of ordinary skill in the art, seeking to control and coordinate the interrelated components would look to a storage device system capable of orchestrating the complexities of the surgical system. Additionally, a person of ordinary skill in the art would consulting Shelton’s situationally aware hub solution would reasonably apprised of how to solve the problem of how to situationally account for and adjust items by their stages of useable life by in light of Shelton’s incorporation by reference of US Patent Application Publication 20160249917 (¶1675). A person of ordinary skill in the art seeking to learn more about tracking an end-of-life parameter, such as adjustment information, would necessarily be drawn to the work of Shelton through a gateway publication to an consider a situational awareness hub as an storage device component and be apprised that the surgical system hub is capable of encompassing all kinds of data, expressly including useable life parameters of the surgical instruments in order to make adjustments as necessary (¶¶1057, 1687).
Because the references address the same engineering problem (surgical systems comprising input couplers, end effectors comprising jaws, actuation assemblies, articulation components, and storage devices storing functional information and settings) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding the hub components and databases to existing surgical systems), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 19, Weir modified by Shelton teaches the surgical system according to claim 18, as set forth above.
Weir teaches wherein the adjustment information includes an articulation angle of the articulating section and a corresponding rotational input to be received by the at least one input coupler as the second input (FIG 9, ¶69 “process 940, wrist articulation is measured. In some examples, the wrist articulation may be measured using one of more position and/or rotation sensors. In some examples, the sensors may be located proximal to the articulated wrist and may be configured to measure each of the articulation angles, such as pitch and/or yaw; FIG 8, scatter plot showing x, y, z axes”).
Regarding claim 20, Weir modified by Shelton teaches the surgical system according to claim 19, as set forth above.
Weir teaches wherein the articulation angle of the articulating section includes at least one of a pitch angle of the articulating section or a yaw angle of the articulating section (FIG 8, scatter plot, x, y, z axes; ¶¶62-64; FIG 9).
Regarding new claim 21, Weir modified by Shelton teaches the surgical system according to claim 1, as set forth above.
Shelton teaches wherein the adjustment information is based on a change in component stiffness (¶1598 power algorithm), a change in component elasticity (¶1598 power algorithm), a change in force transmission across joints or connections (¶1598 force to fire), a change in tolerance (¶1598, force to close), a change in frictional loss (¶1598 impedance), component wear (¶1598, jaw closure rate), component degradation (¶1598 power algorithm), joint degradation (¶1598, jaw closure rate), connection degradation, or a combination thereof.
Regarding new claim 22, Weir modified by Shelton teaches the surgical system according to claim 18, as set forth above.
Shelton teaches wherein the adjustment information is based on a change in component stiffness (¶1598 power algorithm), a change in component elasticity (¶1598 power algorithm), a change in force transmission across joints or connections (¶1598 force to fire), a change in tolerance (¶1598, force to close), a change in frictional loss (¶1598 impedance), component wear (¶1598, jaw closure rate), component degradation (¶1598 power algorithm), joint degradation (¶1598, jaw closure rate), connection degradation, or a combination thereof.
Conclusion
No claim is allowed.
The prior art made of record and not presently relied upon is considered pertinent to applicant's disclosure:
Nixon, US 7,386,365 (10 June 2008) teaches tool grip calibration for robotic surgery.
Nixon, US 20050251110 (10 November 2005) teaches tool grip calibration for robotic surgery.
Tierney et al., US 20180116735 (3 May 2018) teaches surgical robotic tools, data architecture, and use.
Manzo et al., US 9,014,856 (21 April 2015) teaches methods for maximum torque driving of robotic surgical tools.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-W (9am-9pm CST) and R-F (9am-3pm CST).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771